No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.

Use the lowest Aranesp® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with
breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.

To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to
avoid RBC transfusions.

Use ESAs only for anemia from myelosuppressive chemotherapy.

ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.

Discontinue following the completion of a chemotherapy course.

Aranesp® is contraindicated in patients with:

Uncontrolled hypertension

Pure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugs

Serious allergic reactions to Aranesp®

Use caution in patients with coexistent cardiovascular disease and stroke.

Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and
mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.

Control hypertension prior to initiating and during treatment with Aranesp®.

Aranesp® increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or
change in seizure frequency.

For lack or loss of hemoglobin response to Aranesp®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin
response are excluded, evaluate for PRCA.

Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to
erythropoietin have been reported in patients treated with Aranesp®.

This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.

PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp®
is not approved).

If severe anemia and low reticulocyte count develop during treatment with Aranesp®, withhold Aranesp® and evaluate patients for
neutralizing antibodies to erythropoietin.

Permanently discontinue Aranesp® in patients who develop PRCA following treatment with Aranesp® or other erythropoietin protein drugs.
Do not switch patients to other ESAs.

Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp®) in the postmarketing setting.
Discontinue Aranesp® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.